Search This Blog

Tuesday, January 16, 2024

Natera: 'No willful infringement' in Ravgen case

 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that a jury has reached a verdict in the United States District Court for the Western District of Texas regarding a patent infringement lawsuit brought by Ravgen, Inc. against Natera.

Natera noted that the damages award of $57 million was significantly less than the $410 million Ravgen was seeking. In addition, the jury determined there was no willful infringement by Natera.

This decision will have no impact on the Company’s ability to continue serving its customers. The patent at issue has expired.

Natera respectfully disagrees with the jury’s verdict and plans to file an appeal.

https://www.businesswire.com/news/home/20240116910268/en/

US Conducts New 'Preemptive Strikes' On Houthi Launch Sites

 On Tuesday US forces carried out another round of strikes on Houthi sites in Yemen, but this time the operation is being dubbed a "pre-emptive" attack that came in response to militants preparing missile launches on the ground in real time.

"US forces struck and destroyed four Houthi anti-ship ballistic missiles," a Central Command (CENTCOM) statement saud. "These missiles were prepared to launch from Houthi-controlled areas of Yemen and presented an imminent threat to both merchant and US Navy ships in the region."

Over the course of the prior day, two commercial ships were hit by Houthi missiles, including the Zografia, in an incident we detailed earlier.

US defense officials explained of this third significant wave of American strikes against the Houthis, per Politico

The Tuesday attacks were on a much smaller scale and “dynamic” in nature, meaning they were not pre-planned and rather taken in self-defense against missiles that presented an imminent threat to international shipping, one of the officials said. All of the officials were granted anonymity to speak about a sensitive operation before an official announcement.

These Houthi launches targeting Red Sea transit are coming daily at this point, and so it's very likely there will be many more counter-attacks to come from the Operation Prosperity Guardian coalition patrolling off Yemen. CENTCOM has has also continued upping its counter-Iran operations in regional waters, also as Tehran is believed to be supplying the Yemeni rebel group with weapons.

Shell plc multinational oil and gas company has been the latest to suspend tanker operations through the Red Sea. 

In earlier analysis we explained how the number of commercial vessels that have transited the Red Sea/Suez Canal route has more than halved over the past month amid rising tensions off Yemen, but more than 100 ships, including oil tankers, have crossed the water lane since the US and UK navies advised operators on Friday to steer clear of the route.

A total of 114 commercial vessels — including oil tankers, bulk carriers, and container ships — have continued with their routes and transited into or out of the Red Sea through the Bab el-Mandeb Strait, according to vessel-tracking data monitored by Bloomberg.

The Houthis have declared war on Red Sea shipping in connection with Israel's ongoing operation in Gaza. The White House has so far backed away from calling for permanent ceasefire, also as over 100 Israeli hostages remain in Hamas captivity...

While attending the World Economic Forum (WEF) in Davos, national security adviser Jake Sullivan strongly suggested the region will soon see more US offensive strikes in Yemen. "We did not say when we launched our attacks, they’re gonna end once and for all," he warned in the fresh remarks.

https://www.zerohedge.com/geopolitical/us-conducts-new-preemptive-strikes-houthi-launch-sites

'Subtle Changes' to the 2024 ADA Standards of Care in Diabetes

 The new American Diabetes Association Standards of Care-2024 is a really interesting, updated document. There aren't any huge headlines, but there are many subtle changes. I think it's important that people really understand what the guidelines say and how we can apply this to patients.

The guidelines are long. There are 328 pages, and I've read every word. I've summarized into two videos what I really think is important to know. This first video is going to be more of the basic overview, and the second video will discuss treatment of people with type 2 diabetes.

I am most interested in section two, entitled, "Diagnosis and Classification of Diabetes." The reason this section resonates so much with me is because it really characterizes what I do as a diabetologist. Recommendation 2.5 says to classify people with hypoglycemia into appropriate diagnostic categories to aid in personalized management. It then goes on to say, "Diabetes is conveniently classified into several clinical categories, although these are being reconsidered based on genetic, metabolomic, and other characteristics and pathophysiology."

The reason this resonates with me so much is because as I've used continuous glucose monitoring (CGM) more extensively in my patients and as we've had newer treatments for our patients with diabetes, I've learned that there must be many, many different types of diabetes because people vary greatly in how they respond and what their glucose profiles look like. I find that this validates the fact that I often can't really tell what type of diabetes a person has, but I do know they have diabetes. What I do clinically is try to figure out the best way to treat them.

The title of section two has been changed. It used to be called "Classification and Diagnosis of Diabetes," but now it's called "Diagnosis and Classification of Diabetes." Basically, what that means is, first, let's figure out whether this patient does or does not have diabetes and then we'll try to classify it, but it might not fit into those simple categories that we all were trained on. It may not be classic type 1, classic type 2, classic other, or gestational diabetesWhat is this? We really need to think that way.

They also focus on improving the standardization of approaches to diagnostic testing for diabetes. They discuss hemoglobin A1c levels as the go-to tool that most of us use for diagnosing diabetes. They also reinforce the need for a second test to confirm the diagnosis.

The standards now talk about how we see — not uncommonly, particularly when using CGM — that there may be a discordance between the glucose values that we see for CGM or fingerstick and the A1c test results. They discuss the potential need for use of other biomarkers, such as fructosamine, and glycated albumin as an alternative method for measuring states of chronic hyperglycemia.

They also discuss pancreatic diabetes, or diabetes in the context of disease of the exocrine pancreas. They talk about the importance of screening for diabetes in people following an episode of acute pancreatitis. Those individuals should be screened 3-6 months after they've had an episode of acute pancreatitis, and then annually in individuals who have chronic pancreatitis, to make sure they're not developing hyperglycemia.

One of the biggest changes in the guidelines is regarding the use of teplizumab to help people with stage 2 type 1 diabetes slow progression to stage 3 type 1 diabetes. For those of you who want to learn more about this, I would strongly encourage you to read the guidelines because they go into great detail about screening, who should be screened, what antibodies mean, and following patients over time.

Suffice it to say, not all prediabetes is actually pre-type 2 diabetes. In individuals, particularly those who have first-degree family members with type 1 diabetes, screening for islet autoantibodies can be very important in terms of understanding what type of prediabetes they might have.

When you're following these patients over time — so you've diagnosed somebody with positive islet autoantibodies and you want to see if they're developing overt type 1 diabetes stage 3 — you can follow them with an A1c level or with an oral glucose tolerance test. Less specifically, you can follow them with CGM. I have a number of patients that I follow over time to watch to see if they are in fact progressing to stage 3 type 1 diabetes. I think it's important to learn about this concept because we've never had anything before that can help slow progression to overt stage 3 type 1 diabetes.

Turning to bone health, section four includes recommendations for the regular evaluation and treatment of bone health, as well as general and diabetes-specific risk factors for fracture. They did this section in conjunction with the American Society for Bone and Mineral Research. Table 4.5, I think, is really useful because they try to provide specific guidance in monitoring bone mineral density, assessing and preventing fracture risk, and helping clinicians make treatment decisions.

The diabetes-specific risk factors are a lumbar spine or hip T score ≤ -2; frequent hypoglycemic events; diabetes duration of greater than 10 years; use of insulin, thiazolidinediones, and sulfonylurea agents; an A1c > 8%; peripheral and autonomic neuropathy; and retinopathy and nephropathy. I think this really adds to who we think of when we think about bone health in our patients with diabetes.

The ADA Standards of Care in Diabetes-2024 continue to emphasize the very important focus on psychosocial health. The Standards discuss the concern over an increased rate of suicidality among patients with diabetes. In terms of risk screening, it's important to do what is considered appropriate for the patient and follow up accordingly.

In terms of other kinds of screening, the ADA now specifies that diabetes distress screening should be done at least annually, and in some cases, we do this more often in patients who have higher levels of distress to see if we're making a difference.

For depression, the ADA also recommends at least annual screening and more frequent screening in patients who've had a history of depression. I really want to highlight the toolkit that's available to use in helping us care for our patients who have behavioral health concerns. There's a 12-page guide for healthcare providers on how to support adults with type 1 or type 2 diabetes who have a whole host of psychosocial health issues, from anxiety, to depression, to barriers to using insulin.

They also include multiple questionnaires for us to use when we're trying to assess patients, to look at whether they have distress or fear of hypoglycemia. The questionnaires are all in one place. I'm always looking for questionnaires, so it's really great that it's there. They also have a document of handouts for healthcare providers to share with patients that cover topics related to psychosocial health issues. Not only do they give us recommendations, but they also give us this toolkit, which I think is very important.

In terms of the management of patients with type 1 diabetes in pregnancy, the use of CGM is further reinforced in addition to ongoing blood glucose monitoring. However, they do state that there are still not enough data to recommend the use of CGM in gestational diabetes or in pregnancy in people with type 2 diabetes. Now, I personally use CGM in people in both of these categories, but officially, there aren't yet enough data to support this. They also state that CGM use should be individualized based on treatment regimen, circumstances, preference, and needs.

In terms of technology, they basically have an open-ended sentence. They say that diabetes devices should be offered to people with diabetes. There's a greater emphasis on education, and I couldn't stress that enough. I think if you couple a device with education, you can really help people make real changes in terms of their diabetes management.

They also talk about automated insulin delivery systems and advocate for automated insulin delivery initiation in all adults with type 1 diabetes, and even discuss its use at diagnosis. Again, they really go into the use of any of these tools along with education. They also talk, as always, about individualizing the use of technology and discussing with patients what works best for them.

They also have this part in the technology section, which I find really interesting and useful to think about. They think that healthcare providers should consider establishing technology-based competencies, meaning that healthcare providers should actually have a level of training and skill at using these technologies so that they can further help patients. They recommend the use of online tutorials and training videos, as well as written material, to help providers understand the use of these devices.

That ends part 1 of the update on the Standards of Care in Diabetes-2024. Although most of the changes may seem small, they really do represent changes in how we think about our patients and how we think about delivering care, devices, and all sorts of services to our patients who need them.

Stay tuned for part 2, which will discuss management of type 2 diabetes and diabetes complications. Thank you.

Anne L. Peters, MD, is a professor of medicine at the University of Southern California (USC) Keck School of Medicine and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.

https://www.medscape.com/viewarticle/999628

Progressive Lawmakers Line Up Behind Costly Fix For Error They Made In Renewable Energy Plan

 By Mark Glennon of Wirepoints

Oopsie.

When Congress voted to spend hundreds of billions to switch electricity production to solar and wind, it forgot something: transmission lines. New ones will be needed going to the locations of the new power sources, but nobody bothered to figure out who will pay for it or how much it will cost.

Congressmen Sean Casten (D-IL) and Mike Levin (D-CA) introduced a bill last month to fix their omission, largely at your expense. The bill has already picked up 76 co-sponsors, including eight from Illinois.

Grab your wallet. Here are the details:

In 2022, Congress passed the mislabeled Inflation Reduction Act (IRA), which will cost an estimated $1.2 trillionfar exceeding initial claims. The IRA actually was the largest energy bill in U.S. history. Tax credits for renewable energy production, among the biggest elements of the law, are estimated to cost $263 billion.

No cap was placed on those tax credits and they were generous – 30% of project costs. That’s part of the reason for the cost overrun but it also means that new solar and wind production projects are underway. All the better, say IRA supporters.

Now, however, there’s widespread, bipartisan recognition that those projects are futile without transmission linking them into the electrical grid. Progressive economist Paul Krugman, for example, cheered the IRA but wrote despairingly in the New York Times that “we may need a third, bureaucratic miracle to fix the electricity grid and make this whole thing work.”

Casten, also an avid IRA supporter, now admits to the gravity of the problem saying that “80% of the clean energy progress we made with the Inflation Reduction Act will be lost unless we reform transmission and permitting.”

Enter Casten and Levin with their solution, the Clean Electricity and Transmission Acceleration Act (CETA), which they introduced in the House last month.

What’s in it?

More tax credits, which is to say more subsidies by taxpayers. A 30% tax credit would go toward qualifying new transmission lines going to renewable sources. The total amount of credits available is again uncapped.

That’s just part of the 210-page bill. It would also amend the IRA to let the Department of Energy finance transmission facilities designated by DOE as “national interest.”

It would give the Federal Energy Regulatory Commission exclusive siting authority for “national interest” transmission lines, directing FERC to base its decision to exercise such authority on factors that include enabling the use of renewable energy. That’s important because it appears to be an attempt to override growing roadblocks local citizens have been putting up to new renewable projects on their landscape.

The bill also contains a range of provisions under the label of “empowerment.” It would, among many other things, establish an Office of Environmental Justice and External Civil Rights; codify the Office of Environmental Justice and External Civil Rights in the EPA; codify the White House Environmental Justice Interagency Council; provide for development an Interagency Federal Environmental Justice Strategy to address “current and historical environmental injustice,” and designate “Tribal Community Engagement Officers” in each agency.

The bill has 76 House co-sponsors and counting, all Democrats, in addition to Casten and Levin, including Illinoisans Jan Schakowsky, Nicole Budzinski, Jonathan Jackson, Eric Sorensen, Bill Foster, Brad Schneider, Raja Krishnamoorthi and Mike Quigley.

What will all this cost?

So far, I have seen nothing at all from bill sponsors or in the press. As always, cost matters little if the results are green.

But lots of evidence suggests that the cost would certainly be many tens of billions and perhaps hundreds of billions of dollars. For example, interconnection costs sometimes 10 times higher than projects that ultimately got built. Earlier this year, a renewable executive told The New York Times that interconnection costs have become the “no. 1 project killer.” For Texas alone, according to one study, extending the reach of transmission lines to connect more zero-carbon power sources would cost $11 billion by 2035.

And stories abound about individual projects facing huge interconnection problems. CNBC devoted a three-part series to it.

Remember that the cost to the government from tax credits or grants to fix the problem is just the start. Utilities would bear a large part of the remaining cost which gets passed through to consumers in rate increases. Insofar as other private sector investors fund the rest of the price, there’s an opportunity cost of capital that might have been invested elsewhere.

The bill has no chance of passing in its current form in the Republican-majority House. It’s important nevertheless because it represents the progressive starting point of negotiations on a massive problem that both parties recognize. Republicans unanimously opposed the IRA in the House and Senate, but may negotiate a bill to address the problem in order to salvage something of value from what’s already been spent.

The new bill is also important because it reflects the thinking of progressives and what they’d like to do if they regain full control of Congress. “While acknowledging that the bill stood little chance of passage in the current House,” The Hill reported, “Casten said it would serve as an ‘anchor of democratic energy policy when a window opens up to have that conversation again.”

Is the public ready to pay up once again for renewable electricity? Most Americans support renewable sources but want a balance with traditional, fossil fuel sources. Good. That’s sensible. But where’s the balance?

There’s a final, huge kicker near the end of the bill that has nothing to do with energy or transmission lines: It would amend the Civil Rights Act of 1964 to prohibit disparate impact discrimination.

I found the buried section by chance when going through the bill. No bill sponsor or reporter has mentioned it. “Disparate impact” is a critical issue in discrimination cases. It’s about whether the mere fact of unequal outcomes proves illegal discrimination and what excuses there may be for it. It’s complicated, and Supreme Court rulings depend on who is getting sued, among other variables.

Suffice it to say, however, that Section 603 of CETA would vastly expand the scope of what would constitute illegal discrimination under the Civil Rights Act, making it easier to sue based on unequal outcomes.

Why did they hide this proposal in an energy bill. Afraid of what voters would think it they put it up straight as a standalone bill?

Getting back to the main thrust of CETA, when Paul Krugman wrote that it would take a “bureaucratic miracle to fix the electricity grid and make this whole thing work,” he must have been fantasizing about CETA.

CETA is that fantasy and more.

https://www.zerohedge.com/markets/progressive-lawmakers-line-behind-costly-fix-error-they-made-renewable-energy-plan

Some student loan borrowers refusing to pay out of protest

 Millions of borrowers with existing student loans still have not made a payment since the bills resumed in October after a three-year hiatus, and some admit they are refusing to pay out of protest.

In an Intelligent.com survey conducted this month of 1,000 federal student loan borrowers, 25% said they had not made any payments at all, and 9% of those said they were holding off on paying their bills intentionally in an effort to pressure the government into canceling their debts.

student loan forgiveness rally

Activists rally outside the Supreme Court after it struck down President Biden's student debt relief program, on June 30, 2023. (Kent Nishimura/Los Angeles Times via / Getty Images)

Of the nearly one in 10 delinquent borrowers taking part in this "boycott" of student loan repayments, 44% said they believe their protest will lead to the cancellation of some federal student loan debt, while 28% think it is "likely" the boycott will convince the government to cancel all student loan debt, the survey found.

But even if no further debt cancellation comes from the boycott, most of the protesting borrowers believe their efforts will make an impact. 

Eight-six percent told Intelligence.com it is "very" (45%) or "somewhat likely" (41%) that the boycott will draw attention to the student loan debt conversation. Sixty-four percent said they believe it is "highly" (32%) or "somewhat likely" (18%) that the boycott will help elect political candidates who believe in loan forgiveness.

Students protest resuming loan repayments

Student loan borrowers demand President Biden cancel student debt immediately at a rally outside the Supreme Court on June 30, 2023. (Paul Morigi/Getty Images for We The 45 Million / Getty Images)

Financial experts advise against missing student loan payments for any reason.

"Although the frustration behind the student loan boycott is understandable, it’s unlikely to lead to positive change," DebtHammer founder and CEO Jake Hill told the outlet. "Instead, it will destroy the credit scores of those who choose to participate. This may not seem like a major issue in the short term, but failing to pay your student loans can make it more difficult to obtain funding for future purchases."

placeholder

The vast majority, 69%, of borrowers who still have not resumed their loan payments said they have not paid the bills because they cannot afford to. Another 18% said they plan to hold off until September 2024 to resume paying, because that is when more severe consequences for missing payments kick in.

Of the borrowers who have resumed making their payments, 94% told Intelligent that doing so has been financially challenging.

Many borrowers had high hopes that their loans would be wiped out by President Biden's loan forgiveness plan to erase up to $20,000 in debt per borrower, but the Supreme Court struck it down last year.

Since then, the White House has announced other efforts to reduce student loan debt, including erasing $127 billion of debt owed by about 3.6 million borrowers.

https://www.foxbusiness.com/politics/some-student-loan-borrowers-refusing-pay-protest

Alaska Air Passengers Sue Boeing After Door Blows Off 737 MAX 9 Mid-Flight

 Berry v. Boeing - has a nice ring to it, doesn't it?

That's the case that was always inevitably going to be filed against Boeing, resulting from the incident a little more than a week ago where a door blew off a Boeing 737 MAX 9 during mid flight. 

As we noted at the time, a brand new Boeing 737 MAX 9 operated by Alaska Airlines, was forced to make an emergency landing at Portland International Airport shortly after takeoff earlier this month due to its mid-cabin exit door detaching from the aircraft mid-flight. This incident was recorded and shared on social media platform X. 

And now the legal liability deluge is beginning, according to Insurance Journal. Seven passengers on the flight are seeking class action status and suing for physical injuries and emotional trauma,

The complaint reads: “The pressure change made ears bleed and combined with low oxygen, loud wind noise and traumatic stress made heads ache severely. Passengers were shocked, terrorized and confused, thrust into a waking nightmare, hoping they would live long enough to walk the earth again.”

“The force of the depressurization ripped the shirt off a boy, and sucked cell phones, other debris, and much of the oxygen out of the aircraft," the suit continues, according to the article

“Passengers feared they would not survive the flight. Some prayed. Some texted family to express their trepidation. Some gripped and clung to one another. Some adult passengers were crying. Most were eerily subdued in their collective helpless state, muted with masks on.”

"During the flight, a sudden decompression occurred once the door detached, leading to an emergency landing. In video footage captured during the incident, the emergency exit can be seen torn off and oxygen masks deployed. There are no reports of serious injuries," aviation blog Airways Magazine wrote in a note about the incident earlier this month. 

Passengers aboard Flight 1282 reported a sudden and loud noise similar to an explosion, followed by the detachment of the left door plug from the aircraft. This resulted in a rapid and forceful decompression of the cabin, the suit says. 

The IJ report added that Boeing is currently under investigation by U.S. regulators due to the incident. Boeing did not comment about the lawsuit. Dave Calhoun, Boeing's CEO, acknowledged that an issue concerning quality had impacted the safety of one of their jets, though the specifics of the problem are still being determined.

https://www.zerohedge.com/markets/thrust-walking-nightmare-alaska-air-passengers-sue-boeing-after-door-blows-737-max-9-mid

Nurix Fast Tracked for Treatment of Relapsed or Refractory CLL and SLL

 

Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports strategy to broadly develop NX-5948 in CLL and other non-Hodgkin lymphoma indications